Surgical repair kit and its method of use

ABSTRACT

A suture passer comprises a longitudinally extending hollow cannula having a central passage slidingly receivable of a surgical suture; a manually graspable handle connected to the hollow cannula for manipulation thereof, the handle having an upper surface; first guide means, connected to the upper surface of the handle, proximate a proximal end of the handle for releasably, guidingly, holding the surgical suture; second guide means, connected to the upper surface of the handle, distal to the first guide means, for releasably, guidingly, holding the surgical suture. The suture passer can be provided in a kit, for use in the suturing of internal tissue, along with a cannula bender, various hollow surgical needles and surgical suture material. The suture passer finds particular use in the suturing of internal tissues which are at least partially accessible through a body cavity, e.g., arthroscopic surgery.

FIELD OF THE INVENTION

The present invention relates to medical devices for performing surgeryand a surgical repair kit containing the same. More particularly, thepresent invention is directed to a surgical repair kit useful forperforming arthroscopic meniscal repairs.

BACKGROUND OF THE INVENTION

Menisci are tough rubbery "C" shaped cartilage cushions that areattached by ligaments to the top (plateau) of the tibia. They preventthe surfaces of the tibia and femur from grinding against each other andact as the shock absorbers in the knee.

Meniscal tears are a common problem in the United States, menisci arealso located in the shoulder, the most common meniscus injury occurs inthe knee. There are two menisci in each knee. Each year, tens ofthousands of people suffer meniscal tears, particularly in or at thesite of one or both knees. If these tears are not repaired, there may bea progressive deterioration of the cartilage, leading to the painfulrubbing and wearing of bones which had previously been covered bycartilage. This, in turn, leads to inflammatory synovitis, arthritis andother debilitating ailments. Consequently there are at least 30,000 to40,000 meniscal excisions or repairs to the shoulder and the kneeperformed each year.

Men and women between the ages of 18 and 45 experience the majority ofmeniscal tears, usually during athletic activity, such as when twisting,cutting, pivoting, decelerating or when being tackled. When torn, themeniscus may have a longitudinal, horizontal, or radial ("parrot beak")tear.

The damaged meniscus may be diagnosed with the assistance or use ofmagnetic resonance imaging (MRI) and/or an arthroscopic examination.Arthroscopy enables a surgeon to look into the joint using a miniaturevideo camera. In many cases, torn fragments of the meniscus are removedarthroscopically. In other cases, a small tear at the periphery of themeniscus with a very swollen knee joint may be treated by draining thejoint, temporarily restricting the use of the knee, and slowly havingthe patient begin rehabilitative exercises.

However, in other cases, the tears in the meniscus do require surgicalrepair, normally by sewing the torn sections of the meniscus together.The use of the arthroscope greatly aids in the surgical repair of themeniscus by allowing the surgeon to better visualize the small areasbetween which the torn meniscus lies. The arthroscope enables thesurgeon to visualize the interior of the joint and to perform surgerythrough small puncture holes without having to open the joint as hasbeen done in the past.

A number of surgical tools have been developed to assist in suturing,and in particular the suturing of the meniscus.

U.S. Pat. No. 2,808,055 (Thayer) discloses a surgical stitchinginstrument which accommodates a bobbin of suture material and includemeans to feed the suture material to a needle. A slidable thread movingmember is provided for advancing the suture material through the needle.

U.S. Pat. No. 3,476,114 (Shannon, et al.) discloses a ligating implementcomprising an elongated instrument through which a ligature passes toform a loop at one end with a disc. The disc provides a means wherebythe loop may be drawn tight above a severed vessel or the like.

U.S. Pat. No. 3,476,115 (Graeff, et al.) discloses a ligating implementas in Shannon, et al., and includes severing means to preventoverstressing of the locking disc during tightening of the noose.

U.S. Pat. No. 4,493,323 (Albright, et al.) discloses a suturing deviceand a method for its use in arthroscopic surgery. The suturing devicecomprises an elongated tube and plunger which are used to hold andadvance a pair of needles united by a length of suture material.

U.S. Pat. No. 4,641,652 (Hutterer, et al.) discloses an applicator fortying sewing threads which comprises a helical tubular coil connected toa shaft having an axial passage. A catcher loop is extendable throughthe shaft to catch a sewing thread inserted manually into the coilpassage.

U.S. Pat. No. 4,935,027 (Yoon) discloses surgical instruments andmethods for affecting suturing of tissue controlled from a positionremote from the suture site. The invention provides for the continuousfeeding of suture material through opposed forcep jaw members betweenwhich the tissue segments are interposed.

U.S. Pat. No. 5,112,308 (Olsen, et al.) discloses a medical device forand a method of endoscopic surgery. The device includes a dilator havinga tapered end and a central passage which accommodates a guide wire fordirecting the dilator. This device does not include any means wherebythe guide wire may be secured to the dilator or otherwise manipulated inconjunction therewith.

U.S. Pat. No. 4,779,616 (Johnson) discloses a method for snagging an endof a surgical suture during arthroscopic surgery, comprising deploying adistal end of a cylindrical cannula adjacent to the end of the suturewithin the body and passing a resilient loop through the cannula to snagthe suture.

U.S. Pat. Nos. 4,890,615, 4,923,461 and 4,957,498 (Caspari, et al.)disclose a suturing instrument and method of use in arthroscopicsurgery. The suturing instrument includes a hollow needle forpenetrating tissue to be sutured within the body while the tissue isclamped between relatively moveable jaws and a suture feed mechanism forfeeding suture material through the hollow needle. The jaws can beopened and the suturing instrument withdrawn from the body, pulling thefree end segment of the suture material with the instrument.

SUMMARY OF THE INVENTION

It is an object of the present invention to provide a surgical repairkit. In particular, it is an object of the present invention to providea surgical repair kit which is particularly suited for the repair oftorn menisci.

It is another object of the present invention to provide a suture passerhaving means for positioning of the suture.

It is another object of the present invention to provide a parallelneedle guide to allow for an easier and more successful placement of asecond needle in close proximity to the first needle that has beenpreviously inserted in the area of a tissue tear.

While the present invention is primarily concerned with the repair oftorn menisci, the repair kit, the parallel needle guide, and the suturepasser may be used in other surgical procedures, e.g. for suturinginternal tissue at least partially accessible through a body cavity.

The suture passer of the invention comprises a longitudinally extendinghollow cannula having a central passage slidingly receivable of asurgical suture and a manually graspable handle connected to the hollowcannula for manipulation thereof. The suture passer has a first guidemeans connected to an upper surface of the handle, proximate to aproximate end of the handle for releasably, guidingly holding thesurgical suture, and a second guide means connected to the upper surfaceof the handle, distal to the first guide means for releasably, guidinglyholding the surgical suture.

In one embodiment of the invention, the hollow cannula is connected tothe upper surface of the handle and the hollow cannula terminates at arearward opening between the first and second guide means.

In another embodiment of the invention, the hollow cannula is receivedwithin a bore formed in the handle, with the bore terminating at anopening in the upper surface of the handle between the first and secondguide means.

The guide means may be loops which are either parallel or transverse tothe longitudinally extending hollow cannula. In an alternativeembodiment, the second guide means may consist of a plurality of bentfingers lying in parallel planes.

The guide means serve as means about which the suture is passed so itmay be manipulated longitudinally with respect to the cannula. Thediameter of the central passage of the cannula is such that the tip of aspinal or similar needle into which the suture is directed may fit intothe cannula and is large enough to allow the sliding passage of twosurgical sutures (i.e. the two limbs of a single surgical suture). Inthe method of use, the suture passer is used in surgical manipulations,and in particular meniscal repairs or other arthroscopic procedures todirect a suture within a joint space with a greater degree of precisionthan available by current methods.

When the two limbs of a surgical suture are within the cannula, theguide means function to separate the two limbs. Separation of the limbsof the surgical suture allows independent manipulation of the suturelimbs. Digital manipulation of the surgical suture between the proximaland distal guide means causes longitudinal passage of one limb of thesurgical suture within the cannula, i.e. friction between the digit andthe said suture will cause the said suture to slide along the topsurface of the handle, into or out of the cannula, when manipulateddigitally.

The surgical repair kit of the present invention comprises a suturepasser, as previously described, at least two surgical needles ofpredetermined length and at least one stylet for each surgical needle.Preferably, the surgical repair kit includes three surgical needles,with one of the surgical needles having a length greater than that ofthe other needles.

In a preferred embodiment, the suture passer is provided with a metalcannula, and the surgical repair kit includes a cannula bender forbending the metal cannula in a desired manner. The cannula bendercomprises a base and a pair of upwardly stepped symmetrical bolsterspositioned on top of the base allowing the cannula to be bent to theright or to the left, each step of each bolster having a predeterminedradius of curvature wherein the radius of curvature of each step issmaller than the radius of curvature of the step immediately below.

Additionally, the surgical repair kit of the present invention mayfurther include a parallel needle guide for guiding the surgical needlesfor desired placement relative to each other. The parallel needle guidecomprises at least three longitudinally extending, hollow tube-shapedunits longitudinally adhered to each other, in a plane, parallel to oneanother, each of the tube-shaped units slidingly receivable of asurgical needle therethrough.

The present invention also provides methods for the suturing of internaltissue which is at least partially accessible through a body cavity. Afirst method comprises the steps of:

(A) providing at least one suture having a first limb and a second limb;

(B) providing a suture passer comprising a longitudinally extendinghollow cannula having a distal opening, a proximal opening and a centralpassage slidingly receivable of a surgical suture;

(C) introducing the distal end of the cannula into a body cavity atleast partially accessing internal tissue to be sutured;

(D) identifying a first insertion site for passing a first limb of asuture through the internal tissue to be sutured;

(E) inserting a first hollow needle through the first insertion site,the hollow needle extending from outside the body through the firstinsertion site into the body cavity;

(F) identifying a second insertion site for passing a second limb of thesuture through the internal tissue to be sutured;

(G) inserting a second hollow needle through the second insertion site,the hollow needle extending from outside the body through the secondinsertion site into the body cavity;

(H) passing the second limb of the suture through the first hollowneedle into the distal opening of the cannula until it exits theproximal opening of the cannula;

(I) feeding the second limb of the suture back into the cannula throughthe proximal opening;

(J) passing the second limb of the suture through the hollow cannulainto the second hollow needle until it exits the needle external of thebody;

(K) drawing the suture through the cannula into the body cavity;

(L) removing the first and second needles by drawing them outwardly ofthe body cavity;

(M) tying the limbs of the suture; and

(N) repeating steps (D)-(M) until a surgically sufficient number ofsutures have been tied.

A second method comprises the steps of:

(A) providing at least one suture having a first limb and a second limb;

(B) providing a suture passer comprising a longitudinally extendinghollow cannula having a distal opening, a proximal opening and a centralpassage slidingly receivable of a surgical suture;

(C) loading the suture passer with a surgical suture such that an end ofthe first limb of the suture and an end of the second limb of the sutureeach protrude from the distal end of the cannula;

(D) introducing the distal end of the cannula into a body cavity atleast partially accessing internal tissue to be sutured;

(E) identifying a first insertion site for passing the first limb of thesuture through the internal tissue to be sutured;

(F) inserting a first hollow needle through the first insertion site,the hollow needle extending from outside the body through the firstinsertion site into the body cavity;

(G) identifying a second insertion site for passing a second limb of thesuture through the internal tissue to be sutured;

(H) inserting a second hollow needle through the second insertion site,the hollow needle extending from outside of the body through the secondinsertion site into the body cavity;

(I) introducing the end of the first limb of the suture into the firsthollow needle until it exits the first hollow needle outside the body;

(J) introducing the end of the second limb of the suture into the secondhollow needle until it exits the second hollow needle outside the body;

(K) drawing the suture through the cannula into the body cavity;

(L) removing the first and second hollow needles by drawing themoutwardly of the body cavity;

(M) tying the limbs of the suture; and

(N) repeating steps (C)-(M) until a surgically sufficient number ofsutures have been tied.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of the suture passer.

FIG. 2 is a top view of another embodiment of the suture passer.

FIG. 3 is a side view of the suture passer of FIG. 2.

FIG. 4 is a frontal view of the handle of the embodiment of the surgicalsuture passer of FIG. 3.

FIG. 5 is a cross section of the handle of the surgical suture passer.

FIG. 6 is a side view of another embodiment of the surgical suturepasser.

FIG. 7A is a side view and FIG. 7B is a top view of another embodimentof the surgical suture passer.

FIG. 8A is an enlarged side view of a tip of a spinal needle and FIG. 8Bis an enlarged side view of a tip of an epidural needle.

FIG. 9 is a side view of a parallel needle guide.

FIG. 10 is a frontal view of a parallel needle guide.

FIG. 11 is a side section view of a needle containing a stylet.

FIG. 12 is a frontal view of a cannula bender.

FIG. 13 is a frontal view illustrating the use of the cannula bender.

FIGS. 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25 and 26 arecross-sectional top views at various stages of an operation where themiddle third of the meniscus is being repaired.

FIGS. 27a, 27b, 28, 29, 30 and 31. are cross-sectional top views atvarious stages of an operation where the posterior region of themeniscus is being repaired.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

FIGS. 1-7 illustrate the meniscal suture passer 1, used for the passageof a suture in a confined area of the body during surgery. The suturepasser 1 comprises a longitudinally extending hollow cannula 2 having acentral passage slidingly receivable of a surgical suture, and amanually graspable handle 3 connected to the hollow cannula 2 formanipulation thereof. A first guide means is connected to the uppersurface of the handle 3 for releasably, guidingly holding the surgicalsuture. A second guide means for guidingly holding the suture, is alsoconnected to the upper surface of the handle 3. The second guide meansis distal to the first guide means. The suture passer 1 in FIGS. 1-6comprises the cannula 2, a handle 3, a rearward opening 4 near theproximal end of the handle 3, a proximal loop 5, and a distal loop 6.The proximal loop 5 serves as the first guide means, and the distal loop6 serves as the second guide means. Proximal loop 5 preferably comprisesa single turn open wire loop having a first axis of rotation of the loopand distal loop 6 is preferably a 11/2 pigtail open wire loop having asecond axis of rotation of the loop. The loops are preferably parallelto one another. In one embodiment, the wire loops 5 and 6 are preferablyperpendicular to the handle 3 with the first axis of rotation and thesecond axis of rotation are transverse to the longitudinally extendinghollow cannula 2. In another embodiment, the axes of rotation of loops 5and 6 are parallel to the longitudinally extending cannula 3. Near theproximal end of the handle there is an opening 4 which leads from thehandle 3 to the cannula 2. The handle is preferably provided withgripping means and is preferably knurled 7, so that the surgeon has abetter grip on the suture passer 1.

The cannula 2 may be attached and enter through an opening at theconcentric center 8 of the handle 3 as shown in FIG. 1. The hollowcannula 2 is received within a bore formed in the handle 3 with the boreterminating at the opening 4 in an upper surface 9 of the handle 3intermediate the first and second guide means. In an alternativeembodiment the cannula may be connected to the upper surface 9 of thehandle 3, as shown in FIG. 3. In this embodiment of the invention, thereis no opening into or through the handle 3. Instead, the hollow cannula2 terminates at a rearward opening 10 between the first and second guidemeans directly on top of the handle 3. Additionally, in the embodimentof FIG. 1, the handle of the suture passer is rounded, whereas in theembodiment of FIGS. 3 and 4, the suture passer handle 3 is flattened onthe side upon which the proximal end of the cannula 2 resides.Additionally, in the embodiment of FIG. 3, the proximal loop 5 resideson the cannula 2 just prior to the proximal opening 4 of the cannula 2.

The central passage of the cannula should have a diameter large enoughto allow sliding passage of two surgical sutures therethrough. Thedistal opening 11 of the cannula should also have a diameter largeenough to allow engagement with the tip of a spinal needle for thepurpose of passage of the suture between the cannula and the needle.

In the embodiment of FIG. 1, the cannula 2 from its distal opening 11 tothe point at which it enters the handle ranges in length from about 6.0cm to about 20.0 cm, and more preferably 12.0 cm in length. The openingof the cannula 2 is preferably from about 0.08 cm to about 0.32 cm inwidth, and more preferably 0.16 cm in width. The wall of the cannula 2is preferably from about 0.01 cm to about 0.05 cm in thickness, and morepreferably, 0.0254 cm in thickness. The handle preferably has a widthranging from about 0.64 cm to about 1.28 cm, and more preferably 0.96 cmin width.

The wire of the wire loops as shown in FIG. 5 ranges from about 0.10 toabout 0.14 cm in diameter "a" and is preferably attached to the handleby a mounting structure 12 about 0.1 to about 0.4 cm in height "h."

In the embodiment of the invention illustrated in FIG. 6, the suturepasser 1 is similar to the invention illustrated in FIG. 3; however, thecannula 2 is flush with the flattened surface of the handle 3 bearingthe wire loops 5 and 6. A segmented piece 13 upon which the proximalloop 5 resides attaches the cannula 2 to the handle 3. The proximalopening be of the cannula opens on the proximal side of the segmentedpiece 13.

In all of the embodiments of the meniscus suture passer 1, the distalloop 6 may be fitted anywhere along the length of the handle. However,it is preferable that the distal loop 6 be fitted about halfway betweenthe ends of the handle of the suture passer.

In yet another embodiment of the invention, shown in FIG. 7, first guidemeans comprises a single turn open loop lying in a first plane, with thefirst plane disposed perpendicularly to the longitudinally extendinghollow cannula, and a second guide means comprising a plurality of bentfingers lying in parallel planes. The planes are parallel to each otherand are perpendicular to the longitudinally extending hollow cannula.The bent fingers may be alternately bent in opposite directions. Asshown in FIGS. 7A and 7B, the second guide means may have 3 bent fingers14, 15, 16.

The suture passer 1 may be made out of either plastic or metal, and acombination thereof, with the handle, loops, or cannula being plastic,metal or any combination thereof. The cannula of the meniscal suturepasser may be semi-rigid. The cannula should be rigid enough tostabilize the inner tear of the meniscus during the insertion of theepidural needle. Additionally, if made of plastic, the cannula should bemalleable enough that it can be bent by hand without the need of aspecial bender. After the cannula is bent it should not spring back.Because of its malleable characteristics, the plastic material is lesslikely to damage the articular surface. If the suture passer is entirelymade out of plastic, the entire suture passer device can be injectionmolded as a single unit. If the handle is made out of plastic material,the loop or the finger projections may be molded as an integral part ofthe handle.

If the suture passer is made out of metal, however, the loops may bescrewed, riveted, or soldered onto the handle of the suture passer.

Frequently, surgical instruments and suturing devices must be adaptableto the environment or conditions in which they are being used. Morespecifically, because of the location of the menisci in the shoulder andin the knee, or because there is limited space in that part of the bodybeing repaired for the placement of surgical tools, especially duringsuturing, it is frequently advisable to adjust the shape of the cannulaof the suture passer or to bend the needles being used during suturingto allow for the positioning of the instruments into or through thesurgical incision to allow for maximum visibility on the part of theoperating team and to avoid crowding of the incision area which wouldhinder the operating team.

Preferably included in the surgical repair kit when the cannula is madeout of metal is a cannula bender. The cannula bender may be used to bendthe cannula without kinking the cannula.

The cannula bender 30 shown in FIGS. 12 and 13 is designed to bend acannula to a desired curvature. It is different from the existing tubeor cannula benders in that it allows the cannula to be bent to variousradii of curvature. The cannula bender 30 can also bend the cannula inmore than one plane.

The cannula bender 30 consists of a base 31 with an approximate diameterof from about 1.25 cm to about 8 cm, with a preferred diameter of about3.8 cm. The base which is preferably curved, circular, or oval in shape,serves as a handle by which the cannula bender is grasped. The base 31may be knurled or striated to provide for a better grip.

There are symmetrical curved bolsters having steps 33, 34, 35, and 36 ontop of the base. The stepped configuration provides the higher steps 34,35 with a smaller radius of curvature. The steps range in height fromabout 0.6 cm to about 4 cm in height, with a preferred height of about 1cm. (Two steps are illustrated but more can be provided).

The cannula 2 is bent against the bolsters 33 or 36 to create thedesired curvature. If a greater degree of curvature is required thecannula may be bent against the higher bolsters 34 or 35 that have asmaller radius. The symmetry of the bolsters allows the cannula to bebent to the right or to the left without having to rotate the cannulabender. This allows for a faster, easier use of the cannula bendershould the need arise during surgery.

The cannula can be bent again in a different plane by rotating thecannula while maintaining the cannula bender in the same orientation.The pre-bent cannula can be contoured against the bolster in a secondplane as long as the curvature is less than the height of the step ofthe bolster.

The entire cannula does not have to be bent, if at all. The purpose ofbending the cannula is for the convenience of the surgeon in passing thesuture to and from the needle(s) to the suture passer, and to manipulatethe suture passer, to reach an area in the cavity or joint that wouldotherwise be inaccessible by a straight cannula.

In addition to the suture passer device, the surgical repair kit alsocontains at least two and preferably three needles. It is preferred thatthe needles be epidural needles 18, two of which are of the same length,e.g., about 3.5 inches in length, and one of which is longer, e.g.,about 4.75 inches in length. It is also preferred that the needles be 18gauge needles. As seen in FIG. 8A, a spinal needle 17 has a bevelled tipwhich, during repair of the meniscus, may accidently lacerate thearticular cartilage. In contrast, as seen in FIG. 8B, the epiduralneedle 18 has a Huber tip. With the epidural needle it is easier toadvance the needle through tough tissue by using a twisting motion. The"rounded" tip of the epidural needle is less likely to lacerate thearticular surface.

The surgical repair kit preferably comes with at least two needles ofthe same length because the needle which is inserted first becomes bluntafter several insertions. The insertion of the second, generally longer,epidural needle is easier with the use of the parallel needle guide 19as shown in FIGS. 9 and 10. (Longer and shorter needles are utilized toprevent the hubs 29A of adjacent needles from interferring with oneanother by staggering the hub distance from the patient's body). Theparallel needle guide allows for the proper alignment of the needlesthrough which the suture will pass. The parallel needle guide is aseries of at least three, and preferably four to five hollow tube shapedunits 20 longitudinally adhered to each other one on top of the other ina parallel formation. The opening or diameter of each tube shaped unitshould be large enough to allow for the passage of an 18 or 21 gaugeneedle to pass through. The parallel needle guide may be made out ofplastic, paper or metal. The parallel needle guide may be from a mold,or the individual tubes may be individually formed and bonded to eachother. Any method of forming the structure is acceptable.

Additionally, there is at least one stylet typified by stylet 29 shownin FIG. 11 in the surgical repair kit for each needle included in therepair kit. The stylet is kept in the needle until the needle is passedthrough the meniscus. This prevents the needle(s) from being cloggedwith tissue and cartilage as it is pushed through the cartilage. Aneedle clogged with tissue will, of course, not allow the suture to bepassed through the needle to the suture passer.

A template (not shown) is preferably included in the surgical repairkit. This template, which may be printed on the back of the surgicalrepair kit container, may be printed on a paper guide inside themeniscal repair kit, or may be provided on, or as, a plastic guide. Thetemplate is used as a guide for the bending of the cannula.

Each of the items included in the surgical repair kit is sterile.Additionally, each item in the surgical repair kit is preferablyindividually packaged in sterile plastic, paper, metal foil, orcombinations thereof. The packaging should be easy to open, so that thecontents thereof are not damaged or do not fall on the operating floorwhile opening. The content of the package and the packaging may besterilized with ethylene oxide or by radiation, or any otherconventional method for the sterilization of packaged elements.

The surgical repair kit which includes the suture passer, at least twosurgical needles of predetermined length, and at least one stylet foreach needle, may also contain an optional third needle of greater lengththan the other two needles, the parallel needle guide, and a template.If the cannula is made of metal, a cannula bender may be included in therepair kit. While the repair kit may be used for any surgery, the repairkit is extremely useful in meniscal repair.

In repairing the middle third of a meniscus, an arthroscope 37 shouldenter through an ipsilateral portal 38 as shown in FIG. 14. The suturepasser 1 should enter through the contralateral portal 39. The epiduralneedle is loaded through the hole on one end of the needle guide using aone handed technique to avoid accidental puncture of the surgeon'sopposite hand.

There are three methods of identifying the insertion points for theneedles.

The first method is to view the meniscal tear with the arthroscope, withthe synovial meniscal junction in view, and then advance the arthroscopeto the synovial meniscal junction. The light from the arthroscope willtransilluminate the skin. The point of insertion of the epidural needleshould be slightly distal to this light.

The second method of determining where to insert the needles is to viewthe meniscal tear and to keep the synovial meniscal junction in view.Palpate along the joint line with a tip of a finger or a meniscal probe.The area of maximal wall motion at the synovial meniscal junctionindicates the point at which the epidural needle should be inserted.

The third method is the easiest method in determining the needleinsertion point, if the synovial meniscal junction is accessible to thesuture passer. The tip of the suture passer is pushed against thesynovial meniscal junction and the skin is palpated, with the finger.The area of the tip will indicate the approximate location where theneedle should be inserted.

The needles may be advanced with a twisting motion if difficulty isencountered in penetrating the tough meniscal tissue. As shown in FIG.15, an inner rim 40 of a meniscal tear 41 may be buttressed with the tipof the cannula 2 of the suture passer to stabilize it against theadvancing needle 18.

Using the parallel needle guide, two epidural needles are insertedthrough the guide and across the meniscal tear with a long epiduralneedle 42 being inserted through the needle guide at a desiredseparation distance from the shorter needle (as shown in FIG. 16). Thislonger needle is inserted through the meniscal tissue, preferably behindthe shorter needle. The stylets are removed from the needles. A sutureis passed through the "first" needle. The tip of the cannula of thesuture passer is introduced into the joint cavity through a smallincision. The distal opening of the cannula is placed at or near theopening of the needle through which the suture has been passed. Thereare areas in the joint cavity, although visible through the arthroscopewhich are not accessible with a straight cannula. Consequently, prior tothe introduction of the suture passer, the cannula of the suture passermay be bent on the cannula bender. The curved cannula allows the surgeonto reach remote areas where the meniscus is being repaired.

In a preferred method for passing the suture from the cannula to theneedle, the needle, preferably an epidural needle with a Huber tip,engages the opening of the cannula (FIG. 17). The more posterior needleis advanced into the joint and captures the tip of the needle with thetip of the cannula. For ease of passage, it is preferable that thecannula and needle meet at about a 15°-30° angle. The opening of theneedle should be facing away from the apex of engagment between thecannula and the needle. The suture is passed directly from the cannulainto the tip of the needle or vice versa.

By careful manipulation, a suture 43 is fed through the needle and intothe cannula. With the tip of the cannula and the needle securelyengaged, the suture is fed (FIG. 18) into the hub of the needle until itexits the proximal opening of the handle of the suture passer. It isadvisable to pull the suture three quarters of the way through. Thesuture close to the opening 4 of the cannula is brought forward toengage the proximal loop. The suture is looped onto the distal guide andis threaded back into the cannula. The suture is engaged onto theproximal guide (FIG. 19).

The first needle is removed, and with the two limbs of the suture heldseparately by the proximal and distal loops, one limb of the suture isadvanced by sliding the suture with the index finger over the topsurface of the handle so that the suture emerges from the tip of thecannula (FIG. 20). The suture, via the suture passer, is now fullycontrollable with one hand. The tip of the second needle and the tip ofthe cannula are brought into close proximity and the suture is passedfrom the loaded suture passer into the opening of the second needle andthrough the second needle. The suture is advanced until it exits fromthe hub of the second needle (FIG. 21). The second needle is partiallyremoved so that the tip of the second needle is buried within softtissue 44 (FIG. 22). The suture is disengaged from the guides on thehandle of the suture passer.

While grabbing both ends of the suture, the suture is pulled through thecannula into joint 45 (FIG. 23). With the second needle still in place,a stab incision 46 is made along the shaft of the second needle down tothe level of a joint capsule 47 but not beyond (FIG. 24). The secondneedle is removed and the soft tissue is dissected all the way down tothe joint capsule by spreading the soft tissue with a pair of smallforceps 48 (FIG. 25). The other limb of the suture is then retrievedthrough this "stab incision" with a meniscal probe 49 (FIG. 26) and thesutures are tied after all of the sutures have been put into place.

For a meniscal tear in the more posterior position, the straight cannulacan enter through the ipsilateral portal to reach the posterior horn ofthe meniscus (FIG. 27a). The cannula can also be contoured to reach aspecific zone of the meniscus with the use of the cannula bender and thetemplate for the various zones (FIG. 27b).

During repair of the meniscus, if the tip of the cannula cannot engagethe tip of the needle during initial passage of the suture, the suturemay be fed through the posterior needle into the joint. The suture maythen be retrieved with a snap or a suture retriever 50 (FIG. 28). Thefirst needle is removed and the suture is fed into the cannula in aretrograde direction (FIG. 29). The cannula is advanced into the jointalong the suture. The suture is then looped onto the distal guide andthreaded back into the cannula until it reaches the tip of the cannula.The suture is then engaged onto the proximal guide (FIG. 30).

The suture is then advanced into the tip of the second needle underarthroscopic visualization (FIG. 31). The suture is advanced until itexits from the hub of the second needle. The second needle is slightlypulled back so that the tip of the needle is buried within the softtissue. The suture is disengaged from the guides on the handle of thesuture passer and the suture is pulled through the cannula into thejoint.

The suture passer can also be used to pass the suture from the suturepasser to the hollow needles, instead of vice versa. The suture passeris loaded with a suture so that the suture engages the first and secondguide means with the "beginning" and "terminal" ends of the sutureprotruding from the distal opening of the hollow cannula. The beginningend of the suture is fed from the distal opening of the hollow cannulathrough the opening of the first hollow needle until it exits the firsthollow needle. The terminal end of the suture is passed from the distalopening of the hollow cannula through the opening of the second hollowneedle until it exits the second hollow needle. The suture is thencompletely disengaged from the suture passer, the suture passer isremoved, both hollow needles are removed and the suture is tightened andtied.

By maneuvering the tip of the needle with one hand and the cannula inthe other when both tips are in close proximity, the suture may beadvanced.

In another method, the suture protrudes from the cannula by about 1/2 to1 centimeter. By manipulating the tip of the cannula with the tip of theneedle, one can engage the suture into the tip of the needle and advancethe suture.

An arthroscopic video camera may be used to visualize the suturing. Thesurgeon manipulates the suture preferably while viewing a video monitorconnected to the camera.

A recommended suture for use is the Ethicon "0" PDS suture. The lengthof the suture should be at least 27 inches and preferably 36 inches inlength. With other types of monofilament suture, the strand tends to becurled when removed from the packaging. It is necessary to straightenout the suture prior to use, as the ends of the suture must be straightfor ease of passage of the suture between the cannula and the needle.

It is preferable that the suture being used have distinct markings togive an enhanced visual indication of the movement of the suture.Different types and colors of markings along the length of the suturewill indicate how much suture has been advanced. It is preferred thatthe suture have distinct markings at the beginning and terminal ends ofthe suture, which could indicate the length of the suture which has beenadvanced.

If the meniscal tear is large, the repair operation should begin at theanterior portion of the tear. After the placement of the anteriorsuture, it will be easier to work along the anterior joint line to theposterior part of the tear. The medial meniscus is repaired with theknee in near extension or slight flexion. The lateral meniscus isrepaired with the knee in 45° to 90° flexion.

The foregoing description of the preferred embodiments of the inventionhas been presented for the purposes of illustration and description. Itis not intended to be exhaustive or to limit the invention to theprecise forms disclosed. Many modifications and variations are possiblein light of the above teachings. It is intended that the scope of theinvention not be limited by this detailed description.

What is claimed is:
 1. A suture passer comprising:a longitudinallyextending hollow cannula having a central passage slidingly receivableof a surgical suture; a manually graspable handle connected to saidhollow cannula for manipulation thereof, said handle having an upperouter surface, said hollow cannula being connected to said upper outersurface of said handle; first guide means, connected to said upper outersurface of said handle at a location approximate a proximal end of saidhandle, for releasably, guidingly, holding the surgical suture; secondguide means, connected to said upper outer surface of said handle at alocation longitudinally displaced from and distal to said first guidemeans, for releasably, guidingly, holding the surgical suture; andwherein said hollow cannula terminates at a rearward opening locatedintermediate the locations of said first and second guide means.
 2. Asuture passer comprising:a longitudinally extending hollow cannulahaving a central passage slidingly receivable of a surgical suture; amanually graspable handle connected to said hollow cannula formanipulation thereof, said handle having an upper outer surface saidhollow cannula being received within a bore formed in said handle; firstguide means, connected to said upper outer surface of said handle at alocation proximate a proximal end of said handle, for releasably,guidingly, holding the surgical suture; second guide means, connected tosaid upper outer surface of said handle at a location longitudinallydisplaced from and distal to said first guide means, for releasably,guidingly, holding the surgical suture; and wherein said bore terminatesat an opening in said upper outer surface of said handle intermediatethe locations of said first and second guide means.
 3. A suture passercomprising:a longitudinally extending hollow cannula having a centralpassage slidingly receivable of a surgical suture; a manually graspablehandle connected to said hollow cannula for manipulation thereof, saidhandle having an upper outer surface; first guide means comprising asingle turn open loop, having a first axis of rotation of said loop,said first guide means being connected to said upper outer surface ofsaid handle at a location proximate a proximal end of said handle, forreleasably, guidingly, holding the surgical suture; and second guidemeans comprising a one and one-half turn open loop, having a second axisof rotation of said loop, said second guide means being connected tosaid upper outer surface of said handle at a location longitudinallydisplaced from and distal to said first guide means, for releasably,guidingly, holding the surgical suture.
 4. The suture passer accordingto claim 3, wherein said first axis of rotation and said second axis ofrotation are parallel to one another.
 5. The suture passer according toclaim 4, wherein said first axis of rotation is transverse to saidlongitudinally extending hollow cannula.
 6. The suture passer accordingto claim 4, wherein said first axis of rotation is parallel to saidlongitudinally extending hollow cannula.
 7. A suture passer comprising:alongitudinally extending hollow cannula having a central passageslidingly receivable of a surgical suture; a manually graspable handleconnected to said hollow cannula for manipulation thereof, said handlehaving an upper outer surface; first guide means comprising a singleturn open loop lying in a first plane, said first plane disposedperpendicular to said longitudinally extending hollow cannula, saidfirst guide means being connected to said upper outer surface of saidhandle at a location proximate a proximal end of said handle, forreleasably, guidingly, holding the surgical suture; and second guidemeans comprising a plurality of bent fingers, each of said bent fingerslying in a plane, each of said planes containing said bent fingers beingparallel to one another and perpendicular to said longitudinallyextending hollow cannula, said second guide means being connected tosaid upper outer surface of said handle at a location longitudinallydisplaced from and distal to said first guide means, for releasably,guidingly holding the surgical suture.
 8. The suture passer according toclaim 7, wherein said plurality of bent fingers are alternately bent inopposite directions.
 9. The suture passer according to claim 7, whereinsaid second guide means comprises three bent fingers.
 10. A surgicalrepair kit comprising:a suture passer comprising: a longitudinallyextending hollow cannula having a central passage slidingly receivableof a surgical suture; a manually graspable handle connected to saidhollow cannula for manipulation thereof, said handle having an upperouter surface; first guide means, connected to said upper outer surfaceof said handle at a location proximate a proximal end of said handle,for releasably, guidingly, holding a surgical suture; second guidemeans, connected to said upper outer surface of said handle at alocation longitudinally displaced from and distal to said first guidemeans, for releasably, guidingly, holding a surgical suture; at leasttwo surgical needles of predetermined length; and at least one styletfor each surgical needle.
 11. The surgical repair kit according to claim10, wherein said surgical needles are epidural needles.
 12. The surgicalrepair kit according to claim 11, wherein said epidural needles have aHuber tip.
 13. The surgical repair kit according to claim 10, furthercomprising a third needle.
 14. The surgical repair kit according toclaim 13, wherein said third needle has a length greater than that ofsaid surgical needles.
 15. The surgical repair kit according to claim10, wherein said suture passer comprises a metal cannula.
 16. Thesurgical repair kit according to claim 15, further comprising a cannulabender for bending said metal cannula, said cannula bender comprising abase, a pair of upwardly stepped symmetrical bolsters positioned on topof said base allowing said cannula to be bent to the right or to theleft, each step of each bolster having a predetermined radius ofcurvature wherein the radius of curvature of each step is smaller thanthe radius of curvature of the step immediately below.
 17. The surgicalrepair kit, according to claim 16, wherein the height of each step issubstantially greater than the diameter of the cannula.
 18. The surgicalrepair kit according to claim 10, further comprising a parallel needleguide for guiding said needles, said parallel needle guide comprising atleast three longitudinally extending, hollow, tube-shaped unitslongitudinally adhered to each other, in a plane, parallel to oneanother, each of said tube-shaped units slidingly receivable of asurgical needle therethrough.